TM Owner Astellas Pharma
Xospata 40mg Tablet
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Indications & Clinical Uses
- Xospata 40 mg is a film-coated tablet containing gilteritinib, a targeted kinase inhibitor taken by mouth for cancer of the blood.
- It is approved, as a single medicine (monotherapy), for adults with relapsed or refractory acute myeloid leukaemia (AML) whose leukaemia cells carry a FLT3 (FMS-like tyrosine kinase 3) mutation; the treating specialist confirms this with a test.
- The recommended starting dose is 120 mg, which is three 40 mg tablets, once daily; the EU label allows an increase to 200 mg if there is no response after 4 weeks.
- Xospata is a specialist-prescribed cancer medicine that you take yourself at home.
- The US label carries a boxed warning for differentiation syndrome, which can be fatal or life-threatening if not treated.
Side Effects
- The most common reactions in the US label (20% or more of patients) were increased liver enzymes (transaminases), muscle and joint pain, tiredness or malaise, fever, mouth and gut sores (mucositis), swelling (oedema), rash, non-infectious diarrhoea, breathlessness, nausea, cough, constipation, eye problems, headache, dizziness, low blood pressure, vomiting and kidney impairment.
- BOXED WARNING: Xospata can cause differentiation syndrome, which can be fatal or life-threatening if not treated; it occurred in about 3% of patients from day 1 up to about day 82.
- Symptoms include fever, cough or difficulty breathing, rash, low blood pressure, rapid weight gain, swelling of the arms or legs and reduced urine output.
- Other serious effects are posterior reversible encephalopathy syndrome (about 1%), QT prolongation and pancreatitis (about 4%).
- Report any of these symptoms to your healthcare team immediately.
Precautions & Warnings
- Boxed warning: differentiation syndrome can be fatal, and treatment with corticosteroids and close monitoring is started if it is suspected.
- An ECG is done before starting and on set days during treatment because Xospata can prolong the QT interval; low potassium or magnesium must be corrected first, and dosing is interrupted and reduced if QTcF exceeds 500 msec.
- Report seizures, confusion, worsening headache or vision changes (PRES) and severe stomach pain that does not go away (pancreatitis).
- Xospata can harm an unborn baby and is contraindicated in pregnancy in the EU: women should use effective contraception during treatment and for 6 months after the last dose, and men for 4 months.
- Do not breastfeed during treatment and for 2 months after the last dose.
- The effect of severe liver or kidney impairment is unknown.
- Swallow tablets whole; do not break, crush or chew.
- Store at 20°C to 25°C.
Avoid Interactions
- Medicines that reduce efficacy: avoid combined P-gp and strong CYP3A inducers, which can lower gilteritinib levels.
- Medicines that increase exposure or toxicity: strong CYP3A inhibitors can raise gilteritinib levels, so your healthcare team will monitor you more closely for side effects.
- Gilteritinib can change the levels of medicines carried by the P-gp, BCRP or OCT1 transporters, and dose adjustment may be needed.
- Avoid medicines that act through 5-HT2B or sigma nonspecific receptors unless essential, because Xospata may reduce their effect.
- Certain medicines that prolong the QT interval add to the risk of heart rhythm problems, so tell your team about all of your medicines.
- Tell your healthcare provider about every prescription medicine, over-the-counter product, herbal remedy and supplement you take.
References
Frequently Asked Questions
Xospata (gilteritinib) is a tablet for adults with acute myeloid leukaemia (AML) that has come back or not responded to treatment and carries a FLT3 mutation. In the EU it is used on its own as monotherapy. A test confirms the mutation before you start.
The usual starting dose of Xospata (gilteritinib) is 120 mg, three 40 mg tablets, taken by mouth once daily at about the same time, with or without food. Swallow the tablets whole and do not break, crush or chew them. If you miss a dose, take it as soon as possible, at least 12 hours before your next dose.
Common Xospata side effects include raised liver enzymes, muscle and joint pain, tiredness, fever, mouth sores, swelling, rash, diarrhoea and breathlessness. Xospata has a boxed warning for differentiation syndrome, which can be fatal. Get urgent help for fever, cough or trouble breathing, rapid weight gain, swollen arms or legs, low blood pressure or passing less urine.
Avoid strong CYP3A inducers combined with P-gp inducers while taking Xospata (gilteritinib), as they can lower its effect. Strong CYP3A inhibitors may raise its levels, so your team will monitor you. Do not breastfeed during treatment or for 2 months after, and tell your healthcare provider about every medicine and supplement you take.
Xospata (gilteritinib) can lengthen the QT interval, so you will have an ECG before starting and on set days during treatment, and low potassium or magnesium must be corrected. You will also be watched for differentiation syndrome, pancreatitis, and PRES signs such as seizure, confusion or vision changes.
No. Xospata (gilteritinib) can harm an unborn baby and is contraindicated in pregnancy in the EU. Women should use effective contraception during treatment and for 6 months after the last dose, and men for 4 months. Do not breastfeed during treatment or for 2 months after the last dose.
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